Introduced in 1982, Accutane (generically known as isotretinoin) quickly became known as both a “miracle drug” and one of the most controversial pharmaceuticals on the market. Accutane was seen as a welcome relief to patients suffering from severe acne that couldn’t be cleared up with other treatments.
Accutane has been prescribed to over 16 million people since it was introduced, and while it is no longer on the market under the brand name, isotretinoin still is— and the side effects remain the same.
Thousands of lawsuits have been filed because of Accutane’s side effects, which include severe depression, birth defects and inflammatory bowel disease (IBD). Hundreds of cases are still pending in court, while derivatives of the drug continue to be prescribed worldwide.
The Federal Drug Administration placed a black box warning on Accutane only two years after it was approved to warn consumers of the risk of fetal deformity. A little over a decade later, several medical studies cite the correlation between the drug’s use and increased feelings of depression, suicide and psychosis. In 2005, the FDA approved a “strengthened risk management plan for Accutane and generic isotretinoin” to make sure its users do not become pregnant while taking this medicine because “isotretinoin causes birth defects.”
The drug was bringing in over $700 million a year for the Swiss company Hoffman-La Roche, who manufactured the drug. In 2000, Accutane sales totaled $759.4 million—8% of total prescription drug sales.
Isotretinoin is a vitamin A derivative that belongs to a group of medications known as retinoids. It works to stop acne from developing by reducing the size of oil glands on the skin and the amount of oil produced. It also slows the growth skin cells in pores, resulting in pores becoming less clogged. Isotretinoin also normalizes keratinization (the shedding of dead skin cells), improves fat metabolism and reduces inflammation—many things isotretinoin opponents argue can be achieved through natural ways through the changing of diet, supplements and skin care.
Isotretinoin is a known teratogen, which causes malformation of an embryo, resulting in birth defects.
Dr. Werner Bollag from Hoffmann-La Roche began studying isotretinoin in 1971 as a treatment for skin cancer. Its effectiveness in clearing up acne was noticed, however Dr. Bollag realized the drug could cause serious birth defects. The compound derived from vitamin A, a known teratogen. A few years later, Hoffman-La Roche began conducting animal studies with isotretinoin—now focusing on its acne clearing ability—resulting in offspring having facial deformities. Subsequently, most patient testing excluded woman, and if they were in the study, they had to provide a negative pregnancy test and contraceptive use. When Roche submitted Accutane for FDA approval in July of 1981, the company reported that no human babies had been exposed to the drug. The lack of human birth defects in testing was a direct result of Roche’s testing conditions. It resulted in the original label of Accutane noting “no evidence for birth defects in humans.”
Upon its release in 1982, FDA Consumer Magazine called Accutane “the biggest breakthrough in acne drug treatment over the last 20 years” and Newsweek reported “there has never been a drug like it.” The FDA classified the drug as a top priority and fast tracked its approval.